Abstract

5560 Background: Grade 3/4 mucositis may occur in >70% of patients (pts) treated with radiochemotherapy (RCT) or radiation therapy (RT) alone for head and neck cancer (HNC). Amifostine is an aminothiol prodrug that protects mucosal tissue from chemotherapy and RT-induced damage. The Evaluating Cytoprotection Health Outcomes Registry prospectively followed 135 pts receiving pretreatment amifostine with RT or RCT in clinical practice. This report describes the incidence of mucositis in pts with HNC who received amifostine before RT or RCT. Methods: Data were collected using clinical report forms and pt questionnaires. Primary end points included the incidence of grade 3 or higher mucositis at any time during treatment. Weight change during treatment was also recorded. Results: Of 135 pts with HNC (101 men, 34 women), 77 (57%) pts received RT only, and 55 (40.7%) received RCT. Treatment details were unavailable for 3 pts. The mean age of pts was 58 years (±12.57 y). The majority of pts (90%) received subcutaneous (SC) amifostine. Data on mucositis incidence and severity were available for 132 pts: 27.3% (36 pts) of this group experienced grade 3 mucositis, and 1.5% (2 pts) experienced grade 4 mucositis. The incidence of grade 3/4 mucositis was lower (25.7%) in pts treated with RT alone than in those receiving RCT (32.7%). Weight change data were available for 127 pts: overall median weight loss was 14.1 pounds; however, 11 (8.7%) pts gained weight during treatment. Conclusions: In this prospective study, the incidence of grade 3/4 mucositis in pts with HNC who received amifostine treatment before RT or RCT was far lower (25.7% to 32.7%) than the 70% or greater incidence previously reported. Since 90% of pts received SC amifostine, these findings also support further investigation of SC administration in pts with HNC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration MedImmune Oncology

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